Orange Book product
ACETADOTE 6GM/30ML (200MG/ML)
Orange Book NDA 021539 · APOTEX INC · Prescription
Key facts
| Proprietary name | ACETADOTE |
|---|---|
| Active ingredients | ACETYLCYSTEINE |
| Strength | 6GM/30ML (200MG/ML) |
| Dosage form | INJECTABLE |
| Route | INTRAVENOUS |
| Application | NDA021539 |
| Applicant holder | APOTEX INC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AP |
| Reference listed drug (RLD) | Yes |
| Reference standard (RS) | Yes |
| Approval date | Jan 23, 2004 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- Yes Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.